Tuttnauer ELARA11-D, Technicial Manual

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Chloride (Cl)
≤0.1 mg/kg
Phosphate (P2O5)
≤0.1 mg/kg
Conductivity (at 20°C)
≤3 μs/cm
pH value (degree of acidity) 5 to 7
Appearance Colourless clean without
sediment
Hardness (Σ Ions of alkaline
earth) ≤0.02 mmol/l
Compliance with the above data should be tested in accordance with
acknowledged analytical methods, by an authorized laboratory.
Note:
We recommend testing the water quality once a month. The use of water for
autoclaves that does not comply with the table above may have severe impact
on the working life of the sterilizer and can invalidate the manufacturer’s
guarantee.
3.12
Directives and Standards
Every autoclave meets the provisions of the following Directives and is in
compliance with the following Standards:
Technical Directives

Medical Device Directive 93/42/EEC.

Pressure Equipment Directive 97/23/EEC.
Technical Standards

EN 13060:2010 ― Small Steam Sterilizers.

EN 61326 ― Electrical equipment for measurement, control and
laboratory use-EMC requirements

IEC/EN 61010A-
1 ― electrical equipment for laboratory use; general
requirements

IEC/EN 61010A-2-
040 ― particular requirements for sterilizers and
washer disinfectors used to treat medical materials.
Quality standards
The manufacturing plant meets the following quality standards:

EN ISO 9001:2008
– Quality System.

ISO 13485:2003
– Quality systems – Medical devices.

The manufacturer retains all supporting documentation.
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